ACOG Statement on FDA Pregnancy Labeling Final Rule

December 3, 2014

Washington, DC – John C. Jennings, MD, President of the American College of Obstetricians and Gynecologists (ACOG), released the following statement addressing the Food and Drug Administration’s updated product labeling rule regarding pregnancy and lactation:

“The American College of Obstetricians and Gynecologists applauds the Food and Drug Administration (FDA) for taking needed steps to increase understanding about the effect of prescription medicines on women during pregnancy and lactation. The FDA’s updated method of presenting information about both risk and benefit will improve the ability of all physicians to treat their pregnant and breastfeeding patients, as well as women who may become pregnant. It will also help more women to understand and take part in their healthcare decision-making.

“As obstetrician-gynecologists, we understand the importance of keeping women healthy before, during, and after their pregnancies, whether they live with chronic conditions or whether they are confronting new diagnoses. And, we recognize that medications can be vital to maintaining a mother's continued good health when pregnant, a goal of central concern in obstetric care. It is essential that all providers have the information they need to safely, effectively, and reliably treat their female patients. We also want to ensure that medicines will help, and not harm, both mother and child.

“Moreover, ACOG hopes that the inclusion of more information on prescription medicine labeling will provide added incentives for clinical research as well as participation in patient registries, to better capture the impact that prescription medicines have on pregnant and breastfeeding women. It is crucial that healthcare providers have access to as much information as possible, and more research will help lead to better care for women in the future.

“ACOG will review the new rule in detail prior to its implementation in June and will develop physician and patient educational resources as necessary.”

ACOG’s Committee Opinion on Research Involving Women can be found here. Information on the FDA final rule can be found here.

The American College of Obstetricians and Gynecologists (The College), a 501(c)(3) organization, is the nation’s leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of more than 58,000 members, The College strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is its companion organization. www.acog.org